HET Bipolar System: Validation of Outpatient Hemorrhoid Treatment (HET)
|ClinicalTrials.gov Identifier: NCT02773420|
Recruitment Status : Unknown
Verified May 2016 by Johan Nordenstam, University of Illinois at Chicago.
Recruitment status was: Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : June 1, 2016
Purpose: The current study aims to evaluate the safety and effectiveness of the HET™ Bipolar System (Medtronic, Boulder, CO) for the treatment of grade I-II hemorrhoids in a prospective pilot study. This device was evaluated retrospectively in a limited cohort of 23 patients previously.
Methods: Patients seen at a colorectal clinic in a single institution with grade I-II hemorrhoids are offered to participate in a prospective pilot trial. The HET device is a modified anoscope equipped with LED lighting, a tissue clamping mechanism and a bipolar energy source used to treat multiple hemorrhoidal columns in one sitting. Three columns of hemorrhoids are treated with 2 heat energy applications per column. The primary outcome is the treatment effect on hemorrhoid symptoms of bleeding, pain, prolapse, itching, and soiling. This is measured with a patient completed questionnaire documenting each symptom's frequency from 0 to 3 (i.e. 0 is < 1x/month; 3 is daily) before therapy and at 3 weeks and 6 month follow-up. Post-treatment pain scores were recorded using the visual analog scale (VAS).
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids||Procedure: HET Application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HET Bipolar System: Validation of a New Minimally Invasive Outpatient Treatment for Symptomatic Hemorrhoids|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||March 2017|
Experimental: HET application arm
Patients with grade I-II internal hemorrhoids will undergo HET application
Procedure: HET Application
The HET device is a modified anoscope equipped with LED lighting, a tissue clamping mechanism and a bipolar energy source used to treat multiple hemorrhoidal columns in one sitting. Three columns of hemorrhoids were treated with 2 heat energy applications per column
- HET Treatment effect on hemorrhoid symptoms [ Time Frame: 3 weeks to 6 months to 1 year ]The effect of HET on symptoms of bleeding, pain, prolapse, itching, and soiling.
- Pain associated with HET [ Time Frame: Immediately to 3 weeks to 2 months ]Evaluation of pain associated with the procedure itself using visual analog scale for pain to record outcome
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773420
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Johan Nordenstam, MD||University of Illinois at Chicago|